KENTEC MEDICAL, INC.

Address:17871 FITCH,Irvine,CA,92614,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Splint, Extremity, Non-Inflatable, External, Non-Sterile (NOC) (5) Warmer, Infant Radiant (FMT) (3) Tube, Feeding (FPD) (2)

Premarket Exempt

Yes No

Clear

AccuTemp Probe - 10817522010199 Catalog Number : 210H

Device Description : ACCUTEMP DISP.SKIN PROBE#210(USE ON C100,C550)w/hydrogel 175 probe cover

Device Class :

Duns Number: 066175613

Premarket Exempt : No

Product Code : FMT

Prescription Use : Yes

Device Count : 1

Ameritus ENFit - 10817522010205 Catalog Number : ENF-40P-80

Device Description : 4fr 80cm single port feeding tube with ENFit connector

Device Class :

Duns Number: 066175613

Premarket Exempt : No

Product Code : FPD

Prescription Use : Yes

Device Count : 1

AccuTemp Probe - 10817522010212 Catalog Number : 230H

Device Description : ACCU-TEMP PROBE #230 FOR USE W/OHMEDAw/hydrogel 175 probe cover

Device Class : 2

Duns Number: 066175613

Premarket Exempt : No

Product Code : FMT

Prescription Use : Yes

Device Count : 1

Ameritus ENFit - 10817522010229 Catalog Number : ENF-50P-90

Device Description : 5fr 90cm single port feeding tube with ENFit connector

Device Class :

Duns Number: 066175613

Premarket Exempt : No

Product Code : FPD

Prescription Use : Yes

Device Count : 1

AccuTemp Probe - 10817522010236 Catalog Number : 232H

Device Description : OHMEDA GIRAFFE OMNI-BED COMPATIBLE TEMP.PROBEw/hydrogel 175 probe cover

Device Class : 2

Duns Number: 066175613

Premarket Exempt : No

Product Code : FMT

Prescription Use : Yes

Device Count : 1

Kentec ArmBoard - 10817522010250 Catalog Number : 403AB

Device Description : 403 size armboard

Device Class :

Duns Number: 066175613

Premarket Exempt : Yes

Product Code : NOC

Prescription Use : Yes

Device Count : 1

Kentec ArmBoard - 10817522010267 Catalog Number : 403ABV

Device Description : 403 size armboard with velcro strap

Device Class :

Duns Number: 066175613

Premarket Exempt : Yes

Product Code : NOC

Prescription Use : Yes

Device Count : 1

Kentec ArmBoard - 10817522010281 Catalog Number : 404AB

Device Description : 404 size armboard

Device Class :

Duns Number: 066175613

Premarket Exempt : Yes

Product Code : NOC

Prescription Use : Yes

Device Count : 1

Kentec ArmBoard - 10817522010298 Catalog Number : 404ABV

Device Description : 404 size armboard with velcro strap

Device Class :

Duns Number: 066175613

Premarket Exempt : Yes

Product Code : NOC

Prescription Use : Yes

Device Count : 1

Kentec ArmBoard - 10817522010311 Catalog Number : 405AB

Device Description : 405 size armboard

Device Class :

Duns Number: 066175613

Premarket Exempt : Yes

Product Code : NOC

Prescription Use : Yes

Device Count : 1

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